Growth
Conditions
Brief summary
The purpose of this research study is to compare the growth and tolerance of infants who consume either an infant formula with intact proteins or an infant formula with partially hydrolyzed proteins through approximately 12 months of age.
Interventions
OTHERCow's milk protein infant formula
A routine cow's milk-based infant formula
OTHERPartially hydrolyzed protein infant formula
A partially hydrolyzed cow's milk protein (PHP) infant formula
Sponsors
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Days to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* 10 to 14 days of age at randomization * singleton birth * Gestational age of 37 to 42 weeks * Birth weight of 2500 g (5lbs 8oz or more) * Exclusively receiving infant formula for at least 24 hours prior to randomization * Parent or legal guardian has full intention to exclusively feed study formula through 120 days of age * Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study * Signed informed consent and authorization to use and disclose Protected Health information
Exclusion criteria
* History of underlying metabolic or chronic disease * Evidence of feeding difficulties or history of formula intolerance * Weight at Visit 1 is \<98% of birth weight * Infant was born large for gestational age from a mother who was diabetic at childbirth * Infant is immunocompromised
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of body weight gain | up to 120 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Quality of Life Family Impact Module | up to 365 days of age | questionnaire |
| Body length | up to 365 days of age | — |
| Head circumference | up to 365 days of age | — |
| Growth Z scores | up to 365 days of age | weight-for-age |
| Recall of study formula intake measured at each study visit | up to 365 days of age | questionnaire |
| Recall of stool characteristics measured at each study visit | up to 365 days of age | questionnaire |
| Medically confirmed adverse events collected throughout the study period | up to 365 days of age | — |
| Specific medically confirmed adverse events related to gastrointestinal | up to 365 days of age | — |
| Specific medically confirmed adverse events related to allergy | up to 365 days of age | — |
| Body weight | up to 365 days of age | — |
| Pediatric Quality of Life Inventory Infant Scales | 120, 180, 275, and 365 days of age | Questionnaire. A 5-point response scale is utilized (0 = never a problem; 4 = always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better functioning (less negative impact). |
Countries
United States
Outcome results
None listed